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Isobide (ISOSORBIDE)
Isobide, also known as Isosorbide, is a small molecule drug originally developed by Alcon and currently owned by the same company. It is classified under the isosorbide drug class and was FDA approved in 1974 for the treatment of ocular hypertension. As an off-patent medication with no active Orange Book patents, Isobide is available as a branded product. Key safety considerations for Isobide include its potential effects on intraocular pressure, which should be closely monitored by healthcare professionals. The commercial status of Isobide is branded, with no generic manufacturers available.
At a glance
| Generic name | ISOSORBIDE |
|---|---|
| Sponsor | Novartis |
| Drug class | Nitrate Vasodilator [EPC] |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 1974 |
Approved indications
- Ocular hypertension
Common side effects
- Cardiospasm
- Palmoplantar keratoderma
- Pruritus genital
- Myocardial infarction
- Sleep terror
- Carotid artery occlusion
- Atrial tachycardia
- Tension headache
- Anosmia
- Subarachnoid haemorrhage
- Immunisation
- Facial pain
Drug interactions
- sildenafil
- tadalafil
- vardenafil
Key clinical trials
- Baroreflex Activation Therapy for Heart Failure (NA)
- Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy (PHASE1,PHASE2)
- DANHEART (H-HeFT and Met-HeFT) (PHASE4)
- Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation (NA)
- Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies (PHASE3)
- Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT) (PHASE3)
- Treatment of Orthostatic Intolerance (PHASE1,PHASE2)
- Effect of Oral Isosorbide Mononitrate Plus Amlodipine Antispasm Therapy on Outcomes of Radial Artery Grafts After CABG (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Isobide CI brief — competitive landscape report
- Isobide updates RSS · CI watch RSS
- Novartis portfolio CI